(90 days)
Not Found
No
The description mentions an "algorithm" but provides no details suggesting it is AI/ML. There is no mention of training data, testing data, or AI/ML specific terms.
No
The device is described as a body fat monitor and body composition analyzer, intended for the estimation of body fat percent and classification of obesity levels. Its function is to provide information and estimations, not to treat or cure any medical condition or affect the structure or function of the body as a therapeutic device would.
No
Explanation: While the device estimates body fat percentage and classifies body fat and obesity levels, which could be used in a diagnostic process, its stated "Intended Use / Indications for Use" is limited to "estimation of body fat percent." It does not claim to diagnose any disease or medical condition. Diagnostic devices are typically used to identify the nature or cause of a disease or health problem.
No
The device description explicitly states that the devices use Bioelectrical Impedance Analysis (BIA) to measure electric resistance by passing a current through the body. This requires hardware components to generate and measure the electrical signal, making it a hardware device with embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Yamato ClockMINI and ClockNAVI Body Fat Monitors use Bioelectrical Impedance Analysis (BIA) to estimate body fat percentage by passing a small electrical current through the body. This is a measurement taken on the body, not from a sample taken from the body.
- Intended Use: The intended use is for estimating body fat percentage, which is a physiological measurement, not a diagnostic test for a disease or condition based on a biological sample.
Therefore, based on the provided information, the Yamato ClockMINI and ClockNAVI Body Fat Monitors are not IVDs. They are considered body composition analyzers.
N/A
Intended Use / Indications for Use
The Yamato ClockMINI and ClockNAVI Body Fat Monitors are intended for use in the estimation of body fat percent in users between the ages of 10 and 80 years old.
Product codes
74 MNW
Device Description
The Yamato ClockMINI Body Fat Monitor -- DF301 (ClockMINI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to estimate body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent. In addition, the ClockMINI classifies the body fat percent into one of four categories: low, average, high, and very high.
The Yamato ClockNAVI Body Fat Monitor - DF311 (ClockNAVI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to measure body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent and a classification of obesity level. The device also calculates Body Mass Index (BMI) from data input by the user and displays an obesity level classification based on the calculated BMI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, arms, and upper torso
Indicated Patient Age Range
10 and 80 years old
Intended User / Care Setting
over-the-counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To show acceptable performance of the Yamato ClockMINI and ClockNAVI devices for estimating body fat percentage, the devices were compared in a Yamato study against the under water weighing (UWW) method. Fifty-one males and 98 females had their body fat percentages estimated by both methods. The two methods provided very similar results overall. In both the male and female populations, the average difference between the Yamato device and the UWW method was extremely small (0.1% m, and -0.2% f) and the standard deviation of the difference was between 3.2% and 3.3%.
Key Metrics
For males, the average difference between the Yamato device and the UWW method was 0.1%, and the standard deviation of the difference was between 3.2% and 3.3%.
For females, the average difference between the Yamato device and the UWW method was -0.2%, and the standard deviation of the difference was between 3.2% and 3.3%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
9. 510(k) Summary
FEB 2 4 2003
510(k) SUMMARY YAMATO ClockMINI and ClockNAVI BODY FAT MONITORS
SUBMITTER INFORMATION
Company name / address: Enscicon Corporation 518 17th Street Suite 1350 Denver, CO 80202
Contact name / numbers:
Clay Anselmo Phone: 800-341-4255 Fax: 303-832-6700
Date summary prepared:
October 22, 2002
Body Fat Analyzer
DEVICE IDENTIFICATION
Trade names:
Yamato ClockMINI Body Fat Monitor, DF301 Yamato ClockNAVI Body Fat Monitor, DF311
Common name:
Classification name:
Impedance Plethysmograph
Omron HBF-306 Body Fat Analyzer
PREDICATE DEVICE
Trade name:
510(k) number:
DEVICE DESCRIPTION
The Yamato ClockMINI Body Fat Monitor -- DF301 (ClockMINI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to estimate body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent. In addition, the ClockMINI classifies the body fat percent into one of four categories: low, average, high, and very high.
The Yamato ClockNAVI Body Fat Monitor - DF311 (ClockNAVI) is an over-the-counter body composition analyzer and clock that uses Bioelectrical Impedance Analysis (BIA) to measure body fat percent by measuring the electric resistance sensed when a 50kHz/500 µ A current is passed through the body. From this measurement the device uses an algorithm to display an estimate of body fat percent and a classification of obesity level. The device also calculates Body Mass Index (BMI) from data input by the user and displays an obesity level classification based on the calculated BMI.
1
INDICATIONS FOR USE
The Yamato ClockMINI and ClockNAVI Body Fat Monitors are intended for use in the estimation of body fat percent in users between the ages of 10 and 80 years old.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
Both of the Yamato devices and the Omron device are battery powered (2 "AAA" batteries) and pass a small electrical current (~500µA, 50kHz) through the hands, arms, and upper torso of the user for the purpose of calculating the bio-electrical impedance of the user. This method is commonly referred to as bio-electrical impedance analysis (BIA.)
The primary indication for use for the Yamato devices and the Omron device is the estimation of body fat percent. The intended user group for all of the devices for normal subjects is 10 to 80 vears. (The Omron device has an "athlete" mode that is not present in the Yamato devices.) The technological characteristics for all the devices are equivalent including the method for estimating body fat percent and the method for calculating body mass index (BMI).
The following primary characteristics of the two Yamato devices are equivalent to the Omron device.
- Method for estimating body fat percent (BIA)
- . Calculation for Body Mass Index (BMI)
- Current and Frequency specifications
- Route of current through the body .
- Data input (height, weight, age, gender) .
- Output parameters (BMI (ClockNAVI only), Body Fat%) .
PERFORMANCE DATA
To show acceptable performance of the Yamato ClockMINI and ClockNAVI devices for estimating body fat percentage, the devices were compared in a Yamato study against the under water weighing (UWW) method. Fifty-one males and 98 females had their body fat percentages estimated by both methods. The two methods provided very similar results overall. In both the male and female populations, the average difference between the Yamato device and the UWW method was extremely small (0.1% m, and -0.2% f) and the standard deviation of the difference was between 3.2% and 3.3%. When considering the variability associated with both methods, including measurement of residual volume in the lung, unpredictability of body water, and the estimation of intestinal tract volume, these numbers are quite small.
CONCLUSION
The Yamato ClockMINI and ClockNAVI Body Fat Monitors are substantially equivalent to the Omron HBF-306 Body Fat Analyzer.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Yamato Corporation c/o Mr. Clay Anselmo Submission Correspondent Enscicon Corporation 518 17th Street Suite 1350 DENVER CO 80202
FEB 2 4 2003
Re: K023942
Trade/Device Name: Yamato ClockMINI Body Fat Monitor, DF301; and Yamato ClockNAVI Body Fat Monitor, DF311 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 18, 2002 Received: November 26, 2002
Dear Mr. Anselmo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Page ___ of ___
| 510(k) Number (if known): | K023942 |
|---|---|
| Device Name: | Yamato ClockMINI (DF301) |
| Yamato ClockNAVI (DF311) |
Indications for Use:
The Yamato ClockMINI and ClockNAVI Body Fat Monitors are intended for use in the estimation of body fat percent in users between the ages of 10 and 80 years old.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leppanen
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number
Over-the-Counter Use.
. (Optional Format 3-10-98)